Percutaneous transcatheter repair of heart valves via trans-apical access

ABSTRACT

Apparatus, systems, and methods are provided for repairing heart valves through percutaneous transcatheter delivery and fixation of annuloplasty rings to heart valves via a trans-apical approach to accessing the heart. A guiding sheath may be introduced into a ventricle of the heart through an access site at an apex of the heart. A distal end of the guiding sheath can be positioned retrograde through the target valve. An annuloplasty ring arranged in a compressed delivery geometry is advanced through the guiding sheath and into a distal portion of the guiding sheath positioned within the atrium of the heart. The distal end of the guiding sheath is retracted, thereby exposing the annuloplasty ring. The annuloplasty ring may be expanded from the delivery geometry to an operable geometry. Anchors on the annuloplasty ring may be deployed to press into and engage tissue of the annulus of the target valve.

CROSS-REFERENCE TO RELATED APPLICATION

This present application is a continuation application of U.S. patentapplication Ser. No. 15/195,433, filed on Jun. 28, 2016 entitled“PERCUTANEOUS TRANSCATHETER REPAIR OF HEART VALVES VIA TRANS-APICALACCESS,” which is a divisional application of U.S. patent applicationSer. No. 13/397,545, filed on Feb. 15, 2012 and entitled “PERCUTANEOUSTRANSCATHETER REPAIR OF HEART VALVES VIA TRANS-APICAL ACCESS,” whichclaims the benefit under 35 U.S.C. § 119(e) of U.S. Provisional PatentApplication No. 61/492,279, filed on Jun. 1, 2011 and titled“TRANSCATHETER FIXATION OF ANNULOPLASTY RINGS,” the disclosures of whichare hereby incorporated by reference herein in their entireties.

TECHNICAL FIELD

The present disclosure relates to treating and repairing heart valves,and specifically to apparatus, systems, and methods for percutaneoustranscatheter delivery and fixation of annuloplasty rings to repairheart valves. Disclosed embodiments are configured to be deliveredthrough a catheter using a trans-apical approach.

BACKGROUND INFORMATION

Heart valve defects, such as regurgitation, may be caused by arelaxation of the tissue surrounding a heart valve (e.g., the mitralvalve or tricuspid valve). This causes the valve opening to enlarge,which prevents the valve from sealing properly. Such heart conditionsare commonly treated by a procedure during which an annuloplasty ring isfixed or secured around the valve. Cinching or securing the tissue tothe ring can restore the valve opening to its approximate original sizeand operating efficiency.

Typically, annuloplasty rings have been implanted during open heartsurgery, so the annuloplasty ring can be sewn into the valve annulus.Open heart surgery is a highly invasive procedure that requiresconnecting a heart and lung machine (to pump the patient's blood andbreathe for the patient), stopping the patient's heart, and cutting openthe thoracic cavity and heart organ. The procedure can expose thepatient to high risk of infection and may result in a long and difficultrecovery. The recovery can be particularly difficult for patients inless than optimal health due to the effects of suffering from a heartvalve defect such as regurgitation.

SUMMARY OF THE DISCLOSURE

Disclosed herein are apparatus, systems, and methods for repairing heartvalves through percutaneous transcatheter delivery and fixation ofannuloplasty rings to heart valves via trans-apical access of the heart.

In certain embodiment, methods are disclosed for repairing a targetheart valve through percutaneous transcatheter delivery and fixation ofan annuloplasty ring to the annulus of the target heart valve viatrans-apical access to the heart. A guiding sheath may be introducedinto a ventricle of the heart through an access site at an apex of theheart. A distal end of the guiding sheath may be positioned retrogradethrough the target valve. The distal end and a distal portion of theguiding sheath are positioned within the atrium of the heart. Anannuloplasty ring arranged in a compressed delivery geometry is insertedinto the guiding sheath. The annuloplasty ring is positioned in thedistal portion of the guiding sheath within the atrium of the heart. Thedistal end of the guiding sheath is retracted back through the heartvalve and into the ventricle of the heart, thereby exposing theannuloplasty ring. The annuloplasty ring may be expanded from thedelivery geometry to an operable geometry. Anchors of the annuloplastyring may be deployed. The anchors may be configured to be pressed intoand engage tissue of the annulus of the target valve. The guiding sheathcan then be retracted from the access site of the heart.

In certain embodiments, a segmented annuloplasty ring may be arranged ina compressed delivery geometry. The annuloplasty ring may be compressedaround a balloon assembly comprising an upper balloon, a lower balloon,a double lumen shaft, and a recess configured to accommodate theannuloplasty ring in the compressed delivery geometry. The upper balloonmay define an upper surface of the recess and the lower balloon maydefine a lower surface of the recess. The double lumen shaft may have afirst lumen coupled to and configured to direct a fluid or gas into theupper balloon from outside the heart and may have a second lumen coupledto and configured to direct a fluid or gas into the lower balloon fromoutside the heart. The annuloplasty ring and at least the upper balloonof the balloon assembly may be positioned through the guiding sheath andwithin the distal portion of the guiding sheath positioned within theatrium of the heart. The distal end of the guiding sheath may beretracted back through the heart valve and into the ventricle of theheart, thereby exposing the upper balloon, the lower balloon, the recessof the balloon assembly, and the annuloplasty ring. The upper balloon ofthe annuloplasty ring may be inflated, at least partially, to a diameterlarger than the diameter of the annulus of the target valve. The lowerballoon of the balloon assembly may be inflated, at least partially, toexpand the annuloplasty ring from the delivery geometry to an operablegeometry. The balloon assembly may be retracted to position theannuloplasty ring planar to a plane of the annulus of the target valveon an atrial surface of the annulus, such that the inflated upperballoon presses the annuloplasty ring against the annulus of the targetvalve.

In certain embodiments, annuloplasty rings are disclosed that include anouter hollow member including a plurality of segments. Adjacent segmentscooperate with one another to allow the annuloplasty ring to expand froma compressed delivery geometry to an expanded operable geometry. Theannuloplasty ring also includes an internal anchor member located atleast partially within the outer hollow member. The internal anchormember includes a plurality of anchors configured to attach theannuloplasty ring to tissue of a heart valve annulus. The internalanchor member is configured to move the plurality of anchors withrespect to a plurality of windows in the outer hollow member toselectively deploy the plurality of anchors through the respectivewindows.

In certain other embodiments, an annuloplasty ring includes anchors andone or more sutures attached to eyelets in the anchors. The one or moresutures may be configured to connect to the anchors through the guidingsheath. Deploying the anchors of the annuloplasty ring includes pullingone or more sutures as the annuloplasty ring is pressed against thetarget valve annulus. Pulling the one or more sutures may cause theanchors to deploy and/or engage the tissue of the annulus of the targetvalve.

BRIEF DESCRIPTION OF THE DRAWINGS

Understanding that drawings depict only certain embodiments and are nottherefore considered to be limiting in nature, non-limiting andnon-exhaustive embodiments of the disclosure are described and explainedwith additional specificity and detail through the use of theaccompanying drawings.

FIG. 1A illustrates a cross-sectional view of a heart accessed by asheath via a trans-apical approach according to one embodiment.

FIG. 1B illustrates a side view of a balloon assembly being deliveredthrough a guiding sheath inserted into a ventricle of the heart via atrans-apical access according to one embodiment.

FIG. 1C illustrates a cross-sectional top view of the balloon assemblywithin the guiding sheath, portraying a delivery configuration of anannuloplasty ring according to one embodiment.

FIG. 1D illustrates a cross-sectional top view of the balloon assemblywithin the guiding sheath, portraying a delivery configuration of anannuloplasty ring according to another embodiment.

FIG. 2 illustrates the guiding sheath retracted through the target valveexposing the balloon assembly of FIG. 1B

FIG. 3 illustrates the balloon assembly of FIG. 1B with the upperballoon inflated.

FIG. 4 illustrates an upper balloon of the balloon assembly of FIG. 1Binflated and retracted to guide and/or secure the position of theannuloplasty ring relative to the annulus of the target valve.

FIG. 5 illustrates the upper balloon and a lower balloon of the balloonassembly of FIG. 1B inflated to expand a diameter of the annuloplastyring.

FIG. 6 illustrates deployment of the anchors of the annuloplasty ring ofthe balloon assembly of FIG. 1B.

FIG. 7 illustrates anchoring of the annuloplasty ring of FIG. 1B.

FIG. 8 illustrates the annuloplasty ring of FIG. 1B anchored into theannulus of the target valve, the balloon assembly, guiding sheath, andguidewire removed, and the heart access site closed.

FIGS. 9A, 9B, and 9C are a flow diagram of a method for repairing atarget heart valve through percutaneous transcatheter delivery andfixation of an annuloplasty ring to the target heart valve viatrans-apical access of the heart according to one embodiment.

FIG. 10 illustrates an annuloplasty ring anchor deployment systemaccording to one embodiment.

FIG. 11 is a simplified schematic diagram illustrating a perspectiveview of a segmented annuloplasty ring according to one embodiment.

FIGS. 11A and 11B are schematic diagrams illustrating a shape memoryhypotube cut to form a plurality of segments for use as an outer tube ofa segmented annuloplasty ring according to one embodiment.

FIG. 11C is a schematic diagram illustrating a cutting pattern used forlaser processing the hypotube shown in FIGS. 11A and 11B.

FIG. 12A is a simplified schematic diagram illustrating a side view ofan internal anchor ribbon including the curved anchors shown in FIG. 11according to one embodiment.

FIG. 12B is a schematic diagram illustrating a top view of the anchorscut into the internal anchor ribbon shown in FIG. 12A in an elongategeometry according to one embodiment.

FIG. 12C is a schematic diagram illustrating a side view of the internalanchor ribbon in an elongate geometry and the anchors in a curled orcurved deployed configuration according to one embodiment.

FIG. 12D is a schematic diagram illustrating a top view of an internalglide ribbon shown in FIG. 12A in an elongate geometry according to oneembodiment.

FIG. 12E is a schematic diagram illustrating a side view of the internalglide ribbon shown in FIG. 12D.

FIGS. 13A and 13B are simplified schematics illustrating cross-sectionside views of an annuloplasty ring before (FIG. 13A) and after (FIG.13B) deployment of the anchors shown in FIG. 12C according to oneembodiment.

FIG. 14A is a schematic diagram illustrating a perspective view of aportion of the annuloplasty ring shown in FIGS. 13A and 13B with adeployed curved anchor according to one embodiment.

FIG. 14B is a schematic diagram illustrating a side view of a portion ofthe annuloplasty ring shown in FIG. 14A.

FIG. 15 is a simplified schematic diagram illustrating a side view ofthe internal glide ribbon shown in FIG. 12A used as a selectivelyadjustable member according to one embodiment.

FIGS. 15A, 15B, and 15C are schematic diagrams of circuitry for using RFinduction to activate the shape memory material of the internal glideribbon according to one embodiment.

FIG. 16A is a schematic diagram illustrating a perspective view of asegmented annuloplasty ring including a plurality of linear anchorsaccording to one embodiment.

FIG. 16B is a schematic diagram illustrating a side view of a portion ofthe annuloplasty ring shown in FIG. 16A.

FIG. 17 is a simplified schematic diagram illustrating a side view of aninternal anchor member including linear anchors according to oneembodiment.

FIG. 18A is a schematic diagram illustrating an enlarged perspectiveview of a single-barbed anchor of a percutaneous transcatheterannuloplasty ring in an affixation configuration according to oneembodiment.

FIG. 18B is a schematic diagram of an enlarged perspective view of adual-barbed anchor of a percutaneous transcatheter annuloplasty ring inan affixation configuration according to one embodiment.

FIG. 19 is a simplified schematic diagram illustrating a side view ofthe internal anchor member shown in FIG. 17 and a selectively adjustablemember according to one embodiment.

FIG. 20 is a schematic diagram illustrating a partial cross-sectionalview of the selectively adjustable member shown in FIG. 19 according toone embodiment.

FIG. 21A is a schematic diagram illustrating a percutaneoustranscatheter annuloplasty ring according to another embodiment.

FIG. 21B is a schematic diagram illustrating an enlarged side view ofthe annuloplasty ring of FIG. 21A according to one embodiment.

FIG. 21C is a schematic diagram of the annuloplasty ring of FIG. 21Awith the anchors in an affixation configuration protruding away from theannuloplasty ring according to one embodiment.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

The present disclosure provides apparatus, systems, and methods forrepairing heart valves through percutaneous transcatheter delivery andfixation of annuloplasty rings to heart valves via trans-apical accessof the heart. An annuloplasty ring that may be flexible and/or segmentedcan be configured in both a compressed delivery geometry that can beinserted into, and delivered through, a catheter tube and an expandedoperable geometry providing a curved and rigid or semi-rigid annularshape. In certain embodiments, an annuloplasty ring may be deliveredpercutaneously to the mitral and/or tricuspid valve annulus of the heartvia a trans-apical approach through a thoracotomy.

Certain annuloplasty rings disclosed herein are small and flexibleenough to be percutaneously delivered into the heart through a catheter,and can be put into a rigid or semi-rigid ring shape and then securelyanchored into the heart valve annulus. Disclosed embodiments enabletrans-apical delivery methods and provide for anchoring and cinching theannuloplasty ring around the valve annulus.

FIG. 1A is a schematic diagram illustrating an example trans-apicalapproach for inserting an annuloplasty ring (not shown) through themitral valve 15 of a heart 10 according to one embodiment. In thisexample, a guiding sheath 104 is shown passing through an access site 11at the apex 30 of the heart 10, through the left ventricle LV, throughthe mitral valve 15, and into the left atrium LA. The annuloplasty ringmay be delivered through the catheter 104 into the left atrium LA andanchored to an annulus of the mitral valve 15. In one embodiment, aneedle or trocar may be used to puncture through the apex 30 to create asmall opening through which a guidewire (not shown) can be insertedthrough the left ventricle LV into the left atrium LA. Then, theguidewire may be used to guide successively larger and stiffer cathetersso as to gradually increase the size of the opening in the apex 30 ofthe heart 10.

As can be appreciated, a trans-apical approach to accessing the heartcan be used to access other chambers of the heart, including, forexample, the right ventricle RV and right atrium RA. Accordingly,subsequent figures do not depict the entire heart, but rather theymerely depict a ventricle and an atrium. A person having ordinary skillin the art appreciates that the ventricle and atrium shown can be anytwo chambers of any heart that are separated by a valve, and that thevalve can be accessed from a tip or apex of the heart proximate to themore “down-flow” of the two chambers of the heart.

FIG. 1B illustrates a partial sectional side view of a balloon assembly106, including an annuloplasty ring 114, being delivered via atrans-apical access site 11, according to one embodiment. A patient'sheart 10 may be exposed minimally and/or visibly via a smallthoracotomy, and the apex of the heart may be pierced with a needle toallow introduction of a guidewire 102. The guidewire 102 may be insertedthrough a ventricle chamber 12 of the heart 10, through a target valve16 of the heart 10, and into an atrium 14 chamber of the heart 10. Aguiding sheath 104 can be inserted over the guidewire 102 and also intothe atrium chamber 14 of the heart 10. The size of the guiding sheath104 may be, for example, between approximately 18 Fr and 24 Fr(approximately 6 mm to 8 mm) in diameter to accommodate the balloonassembly 106. As shown, the guiding sheath 104 may be positionedretrograde through leaflets 18 of the target valve 16.

The balloon assembly 106 can be inserted over the guidewire 102 andthrough the guiding sheath 104. The balloon assembly 106 may include ashaft 108, an upper balloon 110, and a lower balloon 112. A recess 111(or narrow waist) between the upper balloon 110 and the lower balloon112 accommodates and secures the annuloplasty ring 114 on the balloonassembly 106. In FIG. 1B, the annuloplasty ring 114 is in a compresseddelivery geometry around the recess 111 of the balloon assembly 106. Inthe delivery geometry, the plane of the annuloplasty ring 114 may betransverse to a major axis of the guiding sheath 104 and substantiallyparallel to a plane of an annulus 20 of the target valve 16.

FIG. 1C illustrates a cross-sectional view of the balloon assembly 106of FIG. 1B within the guiding sheath 104, according to one embodiment.FIG. 1C portrays a delivery configuration of the annuloplasty ring 114positioned in the recess 111 of the balloon assembly 106 as it isdelivered through the guiding sheath 104. The annuloplasty ring 114 maybe segmented to enable it to fold over itself around the balloonassembly 106 in a delivery geometry. The annuloplasty ring 114 may becompressed and folded within a plane transverse to a longitudinal axisof the guiding sheath 104.

FIG. 1C also depicts a cross-section of the shaft 108 of the balloonassembly 106. The shaft 108 includes a guidewire lumen 116 and a doubleinflation lumen 118. The guidewire lumen 116 of the balloon assembly 106is over the guidewire 102. The double inflation lumen 118 includes anupper balloon inflation portion 118 a and a lower balloon inflationportion 118 b. The double inflation lumen 118 may allow the upperballoon (see FIG. 1B) and the lower balloon 112 to be separatelyinflated. The annuloplasty ring is positioned around the shaft 108 andportions of the lower balloon 112, in the recess 111 of the balloonassembly 106. For sake of clarity, only a portion of the lower balloon112 is shown.

In another embodiment, a portion of an upper balloon may be positionedwithin the recess 111 and configured to expand when inflated to expandthe annuloplasty ring. In another embodiment, the lower ballooninflation portion 118 b may end below the recess 111, such that it wouldnot be visible in the cross-section of FIG. 1C. As can be appreciated,other configurations of a double inflation lumen are possible.

In another embodiment, the balloon assembly 106 comprises a singleballoon including an upper balloon portion (e.g., upper balloon 110shown in FIG. 1B) and a lower balloon portion (e.g., lower balloon 112shown in FIG. 1B) that are more pliant than a recess portion (e.g.,recess 111 shown in FIG. 1B) of the balloon. The recess portion may bemore rigid (e.g., formed of a thicker portion of material forming theballoon assembly 106) than the upper balloon and lower balloon portions.A single inflation lumen 118 may be used to inflate both the upperballoon portion of the balloon assembly 106 and the lower balloonportion of the balloon assembly 106. The more pliant upper and lowerballoon portions may be configured to inflate more readily than therecess portion and, thus, may inflate more rapidly and/or readily than(e.g., before or prior to) the recess portion. Inflation (and expansion)of the upper balloon portion more rapidly than inflation (and expansion)of the recess portion may restrict distal shifting of the annuloplastyring relative to the recess portion, for example, as the deliveryassembly is advanced and positioned in a target valve. Similarly,inflation (and expansion) of the lower balloon portion more rapidly thaninflation (and expansion) of the recess portion may restrict proximalshifting of the annuloplasty ring relative to the recess as the deliveryassembly is advanced and positioned in the target valve. Inflation ofthe balloon assembly may cause expansion of the upper balloon portionand the lower balloon portion initially, and eventually expansion of therecess portion. Expansion of the recess portion may expand theannuloplasty ring from the compressed delivery geometry to an expandedoperable geometry.

FIG. 1D illustrates a cross-sectional top view of the balloon assemblywithin the guiding sheath 104, portraying a delivery geometry of anannuloplasty ring 114′, according to another embodiment. In theembodiment of FIG. 1D, the annuloplasty ring 114′ is configured to havetwo ends that are separated and configured to snap together to form thering-shape of the annuloplasty ring 114′. Because the ends areseparated, the annuloplasty ring, in the compressed delivery geometry,can be wound around the shaft 108 of the balloon assembly and within therecess 111 in a spiral fashion, as shown. The annuloplasty ring 114′ iscompressed (e.g., wound in a spiral) within a plane transverse to alongitudinal axis of the guiding sheath 104. The annuloplasty ring 114′may be formed of a shape memory material configured to restrictexpansion of the annuloplasty ring 114′ beyond a shape that would allowundesired disconnection or separation from the recess 111 of the balloonassembly.

FIGS. 1C and 1D provide example embodiments of an annuloplasty ring anda delivery geometry. A person having ordinary skill in the artappreciates that other delivery geometries are possible.

FIG. 2 illustrates the guiding sheath 104 retracted back through thetarget valve 16 to expose the balloon assembly 106. The upper balloon110, the lower balloon 112 and the recess 111, in which the annuloplastyring 114 is disposed, are exposed outside of and distal to the distalend of the guiding sheath 104. The guiding sheath 104 may be retracted,but not removed from the heart 10 during the procedure to provide achannel by which the balloon assembly 106 can be removed from the heart10 and to maintain access to the target valve 16 should the annuloplastyring 114 need to be retrieved during the procedure.

FIG. 3 illustrates the balloon assembly 106 of FIG. 1B with the upperballoon 110 inflated. The upper balloon 110 may be inflated first tosecure the position of the annuloplasty ring 114 relative to the targetvalve 16. Inflation of the upper balloon 110 may limit undesiredshifting of the annuloplasty ring 114 in a distal direction (toward theend of the balloon assembly and further into the atrium 14),particularly during anchoring of the annuloplasty ring 114. Furthermore,inflation of the upper balloon 110 may prevent the annuloplasty ring 114from popping off (or similarly separating from) the balloon assembly 106during expansion of the annuloplasty ring 114, so that the annuloplastyring 114 cannot be inadvertently separated from the balloon assembly 106prior to anchoring and left to float undesirably in the atrium 14 of theheart 10. Inflation of the upper balloon 110 may be sufficient such thata size (e.g. diameter) of the upper balloon 110 provides a surface toallow a practitioner to pull back on the balloon assembly 106 withoutdrawing the balloon assembly 106 through the target valve 16.

Inflation of the upper balloon 110 to a size larger than the diameter ofthe annulus of the target valve allows the practitioner to exert a forceagainst the atrial surface of the annulus 20 of the target valve 16. Thepractitioner can pull back the upper balloon 110 of the balloon assembly106 against the annulus 20, enabling a positioning force to be appliedto the annuloplasty ring 114. The positioning force can be applied by apractitioner to determine proper positioning of the annuloplasty ring114 for anchoring. The positioning force against the annuloplasty ring114 may also press the annuloplasty ring 114 against the annulus 20 andprevent undesired shifting of the annuloplasty ring 114 duringanchoring.

FIG. 4 illustrates the upper balloon 110 of the balloon assembly 106 ofFIG. 1B inflated to secure the position of the annuloplasty ring 114relative to the annulus 20 of the target valve 16 and the balloonassembly 106 retracted such that the annuloplasty ring 114 is positionedat the level of the annulus 20 of the target valve 16. The annuloplastyring 114 is oriented so as to be planar to the plane P_(v) of the targetvalve 16, on the atrial surface of the target valve 16. The upperballoon 110 and the annuloplasty ring 114 are positioned within theatrium 14 of the heart, above the target valve 16. As illustrated, theinflated upper balloon 110 may restrict proximal movement of the balloonassembly with respect to the target valve 16. Movement of the inflatedupper balloon 110 through the target valve 16 may be impeded by the sizeof the inflated upper balloon 110 relative to a diameter of the annulus20 of the target valve 16.

The lower balloon 112 can be inflated to expand the annuloplasty ring114 from the compressed delivery geometry to an expanded operablegeometry. FIG. 5 illustrates the upper balloon 110 and the lower balloon112 of the balloon assembly 106 of FIG. 1B partially inflated to expandthe annuloplasty ring 114. The upper balloon 110 and lower balloon 112may be further expanded together to further transition the annuloplastyring 114 from the delivery geometry to the operable geometry. Inflationof the balloons 110, 112 may increase the circumference of the recess111, causing the annuloplasty ring 114 to, for example, unfold orotherwise expand. In certain other embodiments, the annuloplasty ring114 may comprise shape memory material configured to automaticallytransition (or spring) back to an operable geometry upon retraction ofthe guide catheter past the annuloplasty ring 114.

FIG. 6 illustrates deployment of anchors 602 of the annuloplasty ring114. The anchors 602 may be barbed prongs configured to protrude fromthe annuloplasty ring 114. In certain embodiments, the anchors 602 maybe deployed automatically as the annuloplasty ring 114 expands, similarto one or more embodiments of annuloplasty rings discussed below. Incertain other embodiment, the anchors 602 may be deployed by apractitioner, similar to one or more embodiments of annuloplasty ringsdiscussed below.

FIG. 7 illustrates anchoring of the annuloplasty ring of FIG. 1B. Theupper balloon 110 and the lower balloon 112 may be further inflated tofurther expand the annuloplasty ring 114 and drive the anchors 602 intothe tissue of the annulus 20. As can be appreciated, in otherembodiments, inflation of either the upper balloon 110 or the lowerballoon 112 alone may be sufficient to expand the annuloplasty ring 114.

FIG. 8 illustrates the annuloplasty ring 114 anchored into the annulus20 of the target valve 16. If the annuloplasty ring 114 is appropriatelypositioned, for example, secured to the annulus 20 on the plane P_(v) ofthe target valve 16, or as otherwise desired by the practitioner, thenthe balloon assembly 106 may be withdrawn and/or otherwise removed,leaving the annuloplasty ring 114 anchored in place at the target valve16. The annuloplasty ring 114 may then be cinched, snapped together, orotherwise reduced in diameter to reduce a diameter of the annulus 20 ofthe target valve 16 to treat regurgitation. Reducing the diameter of theannulus may improve the coaptation of the leaflets such that a gapbetween the leaflets sufficiently closes during left ventricularcontraction, thereby treating regurgitation. Cinching the annuloplastyring, snapping together free ends of the annuloplasty ring, and othermethods of reducing the diameter of the ring once it is implanted arediscussed below in greater detail. The guiding sheath 104 and theguidewire 102 can also be removed and the heart access site 11 can beclosed, for example, with one or more sutures 24.

FIGS. 9A, 9B, and 9C are a flow diagram of a method 900 for repairing atarget heart valve through percutaneous transcatheter delivery andfixation of an annuloplasty ring to the target heart valve viatrans-apical access of the heart. As provided in FIG. 9A, the heart maybe exposed 902, for example, via a thoracotomy done at the fifth orsixth rib of a patient, where the pulse of the heart can be felt on thechest of the patient. A mini-retractor may be positioned at thethoracotomy to maintain patency of the thoracotomy opening. A needle maybe used to pierce 904 the apex of the heart to create an access siteinto the heart. The access site may access a ventricle chamber of theheart, for example, in a human patient. One or more sets of purse-stringsutures may be inserted 906 around the access site so as to provide away to nearly immediately close the access site should there be anemergency or other need to quickly close the opening of the access siteinto the heart. A guidewire may be inserted 908 into the heart, forexample into a ventricle, and through the target valve into an atrium ofthe heart. The guidewire may guide, or otherwise facilitate, insertionof other components to complete the desired valve repair procedure. Forexample, the guidewire may guide insertion 910 of a guiding sheath intothe heart. The guiding sheath may be inserted 910 over the guidewire andretrograde through the target valve into the atrium chamber of theheart. As described above, the guiding sheath may have a diameter in arange of 18 Fr to 24 Fr. Accordingly, insertion of the guiding sheathover the guidewire may include multiple steps of inserting a dilatorover the guidewire to dilate the access site, inserting a larger sheath,and then repeating.

Referring now to FIG. 9B, a delivery assembly, such as a balloonassembly, including an annuloplasty ring in a delivery geometry, may beinserted 912 over the guidewire and through the guiding sheath into adistal portion of the guiding sheath positioned within the atrium. Anexample of an insertion 912 of a balloon assembly, including anannuloplasty ring, is shown in FIG. 1B. With the balloon assemblypositioned within the atrium of the heart, the guiding sheath may beretracted 914 back through the target valve to expose the balloonassembly. The ring may be positioned 916 at the level of the annulus ofthe target valve, planar to the plane of the target valve, above theatrial surface of the target valve. An upper balloon of the balloonassembly may be inflated 918 to guide and/or secure appropriatepositioning of the annuloplasty ring proximate the annulus of the targetvalve. The upper balloon and lower balloon may be concurrently and/orsimultaneously inflated 920 to expand the diameter of the annuloplastyring and/or to transition the annuloplasty ring from the deliverygeometry to an operable geometry. Inflation of the upper balloon alonemay not cause substantial expansion of a recess formed between the upperballoon and the lower balloon. The balloon assembly may be configuredsuch that inflation of the lower balloon, or concurrent inflation of theupper balloon and lower balloon results in expansion of the recess (orwaist) of the balloon assembly.

Referring now to FIG. 9C, the anchors of the annuloplasty ring aredeployed 922. In certain embodiments, the anchors may deployautomatically with expansion of the annuloplasty ring (and/or withtransition of the annuloplasty ring from the delivery geometry to theoperable geometry). In certain other embodiments, a practitioner may beenabled to control deployment of the anchors. Once the anchors are fullydeployed, the anchors (and the annuloplasty ring) can be implanted intothe tissue of the annulus. The upper and lower balloons may be furtherinflated 924 to cause the annuloplasty ring to further expand and drivethe anchors into the tissue of the annulus of the target valve and allowthe anchors to engage the tissue of the annulus. The anchors engage thetissue of the annulus implants and secure the annuloplasty ring to thetarget valve. The upper and lower balloons can be deflated 926, forexample to test securement of the annuloplasty ring and/or to preparefor removal of the balloon assembly from the heart. Proper implantationand/or securement of the annuloplasty ring in the target valve canenable repair of the target valve. The annuloplasty ring can beratcheted and/or cinched 928 to decrease the diameter of theannuloplasty ring, and in turn the annulus of the target valve, whichcan allow the valve leaflets to function properly, eliminateregurgitation, and repair the valve. The balloon assembly, the guidingsheath, and the guidewire can be removed 930 from the heart through theaccess site. Then the heart access site can be closed 932, using forexample the purse-string sutures and/or other closure mechanism ormethod.

Example Anchor Deployment Mechanism

FIG. 10 illustrates an annuloplasty ring anchor deployment system 1000,according to one embodiment. In the illustrated embodiment, theannuloplasty ring 1002 includes a plurality of fish hook shaped, curvedanchors 1004. Each of the plurality of anchors 1004 includes a laserhole (not shown), or other eyelet-type opening, on the anchor 1004. Asuture 1006 may be coupled to the laser hole of each of the anchors1004. The sutures 1006 may be formed of, for example, nylon, prolene, orthe like. The plurality of sutures 1006 coupled to the laser hole maypass through the guiding sheath and out of the patient's body where theycan be manipulated by a practitioner. For example, the practitioner maybe able to pull the sutures 1006 to deploy the anchors and/or to drivethe tips of the anchors into tissue.

A knot pusher 1008 may be disposed on the sutures 1006 to knot and cutthe sutures 1006 once the anchors are deployed. With the annuloplastyring forced down by an upper balloon of a balloon assembly or pulleddown via the catheter onto the annulus, exposed anchors 1004 may startpenetrating surrounding tissue of the annulus of the target valve. Apractitioner can grip each suture 1006, for example, in sequence andattach the knot pusher 1008 with a clip attached to a small ancillarycatheter. The ancillary catheter can be advanced along a presentlygripped suture 1006 to advance a knot (e.g., a loop in the suture),sliding it to an appropriate securement position, and tighten the knot.For example, the knot may be advanced toward the base of theannuloplasty ring 1002. Once the knot is snug against the annuloplastyring 1002, the knot may be tightened and a miniature clip may secure inplace and cut the suture at the level of the annuloplasty ring 1002. Theannuloplasty ring 1002 is thereby secured via both tissue penetration bythe anchors 1004 and added sutures 1006 with knots. As another example,the knot may be advanced to an access site of the suture 1006 and/oranchor 1004 into the surrounding tissue of the annulus of the targetvalve. The knot may then be tightened against the base of the anchor1006 and/or the tissue to secure the anchor in the tissue.

In another embodiment, the knot pusher 1008 may advance a fastener(rather than a loop in the suture 1006) disposed on the suture. Thefastener may have an internal lumen extending axially therethrough andone or more engagement member(s) formed, for example, on an end of thelumen and/or the fastener. Between the engagement members may be definedan engagement aperture that may align with or otherwise be incommunication with, for example, a lumen of an ancillary catheter, whichmay be configured to deploy the fastener. The engagement aperture may besized to receive the suture 1006. Prior to deployment, the engagementmember(s) may be deflected radially away (e.g., outward) from the axisof the fastener such that the engagement aperture has a relatively largefirst diameter sufficient to permit the suture 1006 to slidetherethrough. Accordingly the fastener can move relative to the suture1006 to be advanced and/or withdrawn along the suture 1006.

After the suture 1006 has been retracted or otherwise drawn taught todeploy the anchors 1004, the fastener may be deployed. Upon deploymentthe fastener may be, for example, detached from the ancillary catheterand the engagement members may be urged or permitted to spring back(e.g., inward) toward the axis of the fastener such that the engagementaperture assumes a second smaller diameter compressing and securing thesuture 1006 in place. Preferably the engagement member(s) tend to springtoward a natural position at or toward the axis of fastener. Eachengagement member may further include a pointed tip that, when theengagement member(s) are in the deployed position, engages and restrictsmovement of the fastener relative to the suture 1006. The fastener inthe deployed position may resist proximal movement relative to thesuture 1006, while allowing advancement distally to a desired positionalong the suture 1006, thereby providing a securement mechanism. Thefastener may operate similar to Chinese handcuffs, allowing movement inone direction while restricting movement in the opposite direction. Inanother embodiment, a deployed fastener may resist both proximal anddistal movement relative to the suture 1006. The fastener may bemanufactured from a variety of materials including, for example,Nickel-Titanium (e.g., nitinol) alloys, shape-memory alloys, stainlesssteel, titanium, various plastics, and other biologically-compatiblematerials. The ancillary catheter may provide a cutting mechanism to cutthe suture 1006 (e.g., cut off the excess of the suture 1006) once thefastener is appropriately positioned.

Example Ring Embodiments With Curved Anchors

FIG. 11 is a simplified schematic diagram illustrating a perspectiveview of a segmented annuloplasty ring 1100 according to one embodiment.Additional ring embodiments and discussion of the same may be found inU.S. patent application Ser. No. 13/198,582, which is herebyincorporated herein by reference in its entirety. The segmentedannuloplasty ring 1100 may include a plurality of segments 1102, aplurality of anchors 1104, and a ring closure lock 1106. In FIG. 11, aswell as in other embodiments disclosed herein, the plurality of segments1102 are arranged in a “D-shape” in the operable geometry (e.g., whenimplanted around the annulus). The D-shaped ring 1100 has a certaingeometrical ratio that is in conformance with the anatomical geometry ofthe human mitral valve annulus. For example, the ratio in certainembodiments of the anterior-posterior (A-P) distance to thecommissure-commissure (C-C) distance of the ring 1100 when implanted isin a range between about 0.60 and about 0.70. In one embodiment, theimplanted ratio of the A-P distance to the C-C distance is about 0.62.Artisans will recognize from the disclosure herein, however, that otheroperable geometries may also be used. For example, circular or ovaloperable geometries may be used. By way of example only, and not bylimitation, the table below provides some example dimensions.

Ring implant Shape (mm) Size C-C A-P Ratio 28 28.00 17.36 0.62 30 30.0018.60 0.62 32 32.22 19.84 0.62 34 34.00 21.08 0.62 36 36.00 22.32 0.62

In addition to the operable geometry, the plurality of segments 1102allow the ring 1100 to be placed in a compressed delivery geometry suchthat the ring 1102 can be disposed in a recess of a balloon assembly orother delivery assembly and positioned through a catheter into theheart. As discussed in detail below, in certain embodiments, thesegmented annuloplasty ring 1100 includes a shape memory (e.g., Nitinol)hypotube into which the plurality of segments 1102 is laser cut. Theshape memory hypotube is heat set to a “memorized” annular shape (e.g.,the D-shaped operable geometry). The shape memory hypotube issuperelastic such that applying sufficient stress places the pluralityof segments 1102 into the compressed delivery geometry and releasing thestress allows the plurality of segments 1102 to resume the D-shapedoperable geometry.

The plurality of anchors 1104 are configured to secure the segmentedannuloplasty ring 1100 to the annulus of the heart valve. In certainembodiments, the anchors 1104 are sufficient such that additionalsuturing of the segmented annuloplasty ring 1100 to the valve annulus isnot needed. In FIG. 11, the anchors 1104 are curved in the illustrateddeployed configuration. Anchors in other embodiments may include othershapes, such as linear or helical deployed configurations. In certainembodiments, the anchors 1104 include a shape memory material (e.g.,Nitinol) that is heat set to a deployed configuration (e.g., linear,helical, or curved configuration shown in FIG. 11). Artisans willrecognize from the disclosure herein, that combinations of differentdeployed configurations may also be used.

The anchors 1104 are superelastic such that applying sufficient stressplaces the anchors 1104 into an introduction configuration and releasingthe stress allows the anchors 1104 to resume their respective deployedconfigurations. In certain embodiments, the anchors 1104 lay flatagainst the plurality of segments 1102 in the introduction configurationduring insertion of the ring 1100 through the catheter. As discussedbelow, in other embodiments, the anchors 1104 are retracted inside thesegmented ring 1100 in the introduction configuration during insertionof the ring 1100 through the catheter. In such embodiments, the anchors1104 may be selectively deployed at a desired time (e.g., after thesegmented ring 1100 is properly positioned against the annulus of theheart valve). In certain embodiments, the superelastic property of theanchors 1104 is used to self-propel the anchors 1104 into the annulus ofthe heart valve.

The ring closure lock 1106 is used to secure the two open ends of thesegmented annuloplasty ring 1100 to form a closed ring. As shown in FIG.11, in certain embodiments, the ring closure lock 1106 includes a femalesnap 1110 and a male snap 1112. As discussed below, the segmentedannuloplasty ring 1100 may be “snap locked” using wires or sutures topull the male snap 1112 into the female snap 1110. In certainembodiments, a gap (e.g., between about 3 mm and 5 mm) is left betweenthe female snap 1110 and the male snap 1112 after the anchors 1104 aredeployed within the tissue of the valve annulus. Then, the two ends aresnapped together to provide cinching of the valve annulus. This cinchingis similar to a technique used by surgeons during open heart surgery(e.g., using sutures) to draw the valve annulus into a smaller orimproved shape that reduces regurgitation of blood back through thevalve.

Although not shown in FIG. 11, certain ring embodiments include aselectively adjustable member (discussed below) for changing the sizeand/or shape of the segmented annuloplasty ring 1100 postoperatively tocompensate for changes in the size of the heart and/or the treated heartvalve. Also not shown in FIG. 11, certain ring embodiments include acover disposed about the entire circumference of the segmented ring1100, or selected portions thereof. For example, in certain embodiments,the cover is disposed so as to enclose the plurality of segments 1102,while leaving uncovered at least portions of the ring closure lock 1106(to permit snapping the lock together). The cover may include openingsaligned with windows (discussed below) in the plurality of segments 1102through which the plurality of anchors 1104 is deployed. In otherembodiments, the plurality of anchors 1104 is configured to puncturethrough the cover during deployment. The cover may include abiocompatible material such as Dacron®, woven velour, polyurethane,polytetrafluoroethylene (PTFE), heparin-coated fabric, or the like. Inother embodiments, the cover includes a biological material such asbovine or equine pericardium, homograft, patient graft, or cell-seededtissue.

FIGS. 11A and 11B are schematic diagrams illustrating a shape memoryhypotube 1113 cut to form a plurality of segments 1102 for use as anouter tube (also referred to herein as an “outer hollow member”) of asegmented annuloplasty ring according to one embodiment. FIG. 11A is aplan view of a first side of the hypotube 1113 in which a plurality ofanchor deployment windows 1114 are cut. FIG. 11B is a plan view of asecond side of the hypotube 1113 that is opposite the windows 1114 shownin FIG. 11A. For illustrative purposes, FIG. 11C is a schematic diagramillustrating a cutting pattern 1116 used for laser processing thehypotube 1113 shown in FIGS. 11A and 11B. While FIGS. 11A and 11B showrespective (opposite) sides of the hypotube 1113, the cutting pattern1116 corresponds to the entire hypotube 1113 as if the hypotube were cutalong an axis 1118 of the surface shown in FIG. 11A and unrolled. Thus,for example, each window 1114 shown in FIG. 11A is shown in FIG. 11C asbeing split between a first half of the window 1114(a) and a second halfof the window 1114(b).

The hypotube 1113 includes a through hole 1120, 1121 at each end (or twoperpendicular through holes at each end according to FIG. 11C) to allowone or more pins (not shown) to couple the male and female components ofthe ring closure lock 1106 to respective ends of the hypotube 1113. Thehypotube 1113 also includes a through hole 1122 (the opening 1122 shownin FIG. 11A being represented in FIG. 11C as 1122(a) and 1122(b)). Asshown in FIG. 11C, the hypotube 1113 may also include a window 1124(passing vertically through the hypotube 1113 with respect to the viewsshown in FIGS. 11A and 11B) that allows one or more lines or sutures(not shown) to exit the hypotube 1113. As discussed below, the suturesare used to snap lock the ring and/or to deploy the anchors 1104.

The cutting pattern 1116 shown in FIG. 11C defines the configuration ofthe plurality of segments 1102 and how the segments 1102 interact withadjacent segments as the hypotube transitions from a compressed deliverygeometry shown in FIGS. 1C and 1D to the annular operable geometry shownin FIG. 11. As shown in FIG. 11B, the hypotube in this exampleembodiment includes a “tongue and groove” pattern wherein a tongue 1126of one segment interfaces with a groove 1128 of an adjacent segment asthe inner circumference of the ring is formed. The cutting pattern 1116provides rigidity to the hypotube 1113 in the annular operable geometry,allows the hypotube 1113 to easily transition from the compresseddelivery geometry to the annular operable geometry.

In certain embodiments, deployment of the anchors 1104 is accomplishedusing an internal anchor member that is selectively movable within thehollow tube formed by the plurality of segments 1102. For example, FIG.12A is a simplified schematic diagram illustrating a side view of aninternal anchor ribbon 1200 including the curved anchors 1104 shown inFIG. 11 according to one embodiment. The curved anchors 1104 may beaffixed (e.g., laser welded) to the internal anchor ribbon 1200 ordirectly cut into the internal anchor ribbon 1200 (as discussed withrespect to FIGS. 12B and 12C). Like the anchors 1104, the internalanchor ribbon 1104 includes a superelastic shape memory material (e.g.,Nitinol) that is heat set to the same memorized annular shape as theplurality of segments 1102 (shown in FIGS. 11 and 12A as D-shaped).

The internal anchor ribbon 1200 may be slid (e.g., using wires orsutures) within the hollow tube formed by the plurality of segments 1102of the ring 1100. To reduce friction between the internal anchor ribbon1200 and the plurality of segments 1102, certain ring embodimentsinclude an internal glide ribbon 1210. The internal glide ribbon 1210may include a low-friction material (e.g., as a coating or covering)such as PTFE or other polymer. In addition, or in other embodiments, theinternal glide ribbon 1210 includes a superelastic shape memory material(e.g., Nitinol) that is heat set to the same memorized annular shape asthe plurality of segments 1102 (shown in FIGS. 11 and 12A as D-shaped).Thus, certain embodiments include three D-shaped superelastic members(the outer tube of segments 1102, the internal anchor ribbon 1200, andthe internal glide ribbon 1210), which cooperate to increase therigidity of the ring 1100.

FIG. 12B is a schematic diagram illustrating a top view of the anchors1104 cut into the internal anchor ribbon 1200 shown in FIG. In thisexample, a laser is used to cut the anchors 1104 along a first side1212, a second side 1214 (e.g., in a pointed or tip shape), and a thirdside 1216, while leaving a fourth side 1218 of the anchor 1104 uncut andattached to the internal anchor ribbon 1200. After cutting, the anchors1104 are heat set to the desired memorized shape for the deployedconfiguration. For example, FIG. 12C is a schematic diagram illustratinga side view of the internal anchor ribbon 1200 and the anchors 1104 in acurled or curved deployed configuration according to one embodiment. Theamount of curvature in the deployed configuration of the anchors 1104may depend on the particular application. In the example shown in FIG.12C, the anchors 1104 fold back on themselves such that the prong or tip1220 points parallel to or away from the internal anchor ribbon 1200.FIG. 12D is a schematic diagram illustrating a top view of the internalglide ribbon 1210, and FIG. 12E is a schematic diagram illustrating aside view of the internal glide ribbon 1210, according to oneembodiment.

FIGS. 13A and 13B are simplified schematics illustrating cross-sectionside views of an annuloplasty ring 1300 before (FIG. 13A) and after(FIG. 13B) deployment of the anchors 1104 shown in FIG. 12C according toone embodiment. For illustrative purposes, the ring 1300 in FIGS. 13Aand 13B is shown in an elongate geometry. Artisans will recognize fromthe disclosure herein, however, that the anchors 1104 are generallydeployed when the ring 1300 is in the annular operable geometry.

The illustrated ring 1300 includes an outer tube 1310 (e.g., formed bythe plurality of segments 1102 shown in FIG. 11) including a pluralityof anchor deployment windows 1312. During the manufacturing of the ring1300, and before the ring 1300 is loaded into the catheter, the internalanchor ribbon 1200 and the internal glide ribbon 1210 are inserted intothe outer tube 1310 in a position where the anchors 1104 are preventedfrom exiting through the windows 1312. As shown in FIG. 13A, insertingthe internal anchor ribbon 1200 into the outer tube 1300 prevents theanchors from assuming their fully curved deployed configuration.

For deploying the anchors 1104, the internal anchor ribbon 1200 mayinclude (or may be attached to) a hook or loop 1314 for engaging a wireor suture 1316 that may be pulled by a user through the catheter (e.g.,in the direction of arrow 1318 in FIG. 13A) to move the tip of eachanchor 1104 to a corresponding window 1312. In certain embodiments, theanchors 1104 and windows 1312 are arranged such that the tip of eachanchor 1104 reaches its respective window 1312 at substantially the sametime as the other anchor/window pairs. As shown in FIG. 13B, once thetips of the anchors 1104 reach the respective windows 1312, thesuperelasticity of the anchors 1104 propel the internal anchor ribbon1200 in the opposite direction (as indicated by arrow 1320) as theanchors 1104 spring out the windows 1312 (as indicated by arrow 1322) toresume their curved configurations, which drives the anchors 1104 intosurrounding tissue (e.g., the heart valve annulus). Thus, thesuperelasticity of the anchors 1104 allows the anchors 1104 to beself-propelled into the tissue adjacent or proximate to the ring 1300.

FIG. 14A is a schematic diagram illustrating a perspective view of aportion of the annuloplasty ring 1300 shown in FIGS. 13A and 13B with adeployed curved anchor 1104 according to one embodiment. FIG. 14B is aschematic diagram illustrating a side view of a portion of theannuloplasty ring shown in FIG. 14A. As shown in FIGS. 14A and 14B, theouter tube 1310 may be cut to define segments (such as the plurality ofsegments 1102 shown in FIG. 11). The outer tube 1310 also includes thewindows 1312 (one window shown in FIG. 14A) described above andschematically represented in FIGS. 13A and 13B. As shown in FIG. 14B, incertain embodiments, the deployed anchors 1104 form an angle α (e.g.,approximately 45 degrees) with a plane 1410 of the ring 1300 to providethe anchors 1104 with improved access to the valve annulus when the ringis positioned against the valve annulus. During anchor deployment, theplane 1410 of the ring 1300 is substantially parallel to the plane ofthe annulus of the target valve.

FIG. 15 is a simplified schematic diagram illustrating a side view ofthe internal glide ribbon 1210 shown in FIG. 12A used as a selectivelyadjustable member according to one embodiment. As discussed above,certain ring embodiments include a selectively adjustable member forchanging the size and/or shape of the annuloplasty ring 1100 (shown inFIG. 11) postoperatively to compensate for changes in the size of theheart and/or the treated heart valve. Thus, FIG. 15 illustrates theinternal glide ribbon 1210 in the D-shaped geometry used immediatelyafter implanting the ring, as well as an “activated” geometry or shape1210′ (shown as dashed lines) that further reduces the size of themitral valve annulus in the (A-P) direction (as indicated by arrows1510). Such A-P contraction improves the coaptation of the leaflets suchthat a gap between the leaflets sufficiently closes during leftventricular contraction. In certain embodiments, the activated shape1210′ also expands in the direction of arrows 1512 (the C-C direction)to pull leaflet commissures away from each other, which draws theleaflets closer together and further improves their coaptation. However,in certain other embodiments, the ring 1100 does not expand in thedirection of the arrows 1512.

As used herein, “postoperatively” refers to a time after implanting anannuloplasty ring, such as the segmented annuloplasty ring 1100 shown inFIG. 11 or other rings described in other embodiments, and closing thebody opening through which the ring 1100 was introduced into thepatient's body. For example, the ring 1100 may be implanted in a childwhose heart grows as the child gets older. Thus, the size of the ring1100 may need to be increased. As another example, the size of anenlarged heart may start to return to its normal size after the ring1100 is implanted. Thus, the size of the ring 1100 may need to bedecreased postoperatively to continue to reinforce the heart valveannulus.

Thus, in certain embodiments, the ring 1100 includes a selectivelyadjustable member (e.g., the internal glide ribbon 1210 shown in FIGS.12A and 15) with a shape memory material (e.g., NiTi, Alloy-B) that isresponsive to changes in temperature and/or exposure to a magneticfield. The ring 1100 is adjusted in vivo by applying an energy source toactivate the selectively adjustable member and cause it to change to amemorized shape. The energy source may include, for example, radiofrequency (RF) energy, x-ray energy, microwave energy, ultrasonic energysuch as focused ultrasound, high intensity focused ultrasound (HIFU)energy, light energy, electric field energy, magnetic field energy,combinations of the foregoing, or the like. For example, one embodimentof electromagnetic radiation that is useful is infrared energy, having awavelength in a range between approximately 1750 nanometers andapproximately 11600 nanometers. This type of infrared radiation may beproduced efficiently by a solid state diode laser. In certainembodiments, the implanted ring 1100 is selectively heated using shortpulses of energy having an on and off period between each cycle. Theenergy pulses provide segmental heating that allows segmental adjustmentof portions of the annuloplasty ring without adjusting the entireimplant.

In certain embodiments, the ring 1100 includes an energy absorbingmaterial to increase heating efficiency and localize heating in the areaof the selectively adjustable member. Thus, damage to the surroundingtissue is reduced or minimized. Energy absorbing materials for light orlaser activation energy may include nanoshells, nanospheres and thelike, particularly where infrared laser energy is used to energize thematerial. Such nanoparticles may be made from a dielectric, such assilica, coated with an ultra thin layer of a conductor, such as gold,and be selectively tuned to absorb a particular frequency ofelectromagnetic radiation. In certain such embodiments, thenanoparticles range in size between about 15 nanometers and about 120nanometers and can be suspended in a suitable material or solution, suchas saline solution. Coatings comprising nanotubes or nanoparticles canalso be used to absorb energy from, for example, HIFU, MRI, inductiveheating, or the like.

In other embodiments, thin film deposition or other coating techniquessuch as sputtering, reactive sputtering, metal ion implantation,physical vapor deposition, and chemical deposition can be used to coverportions or all of the selectively adjustable member. Such coatings canbe either solid or microporous. When HIFU energy is used, for example, amicroporous structure traps and directs the HIFU energy toward the shapememory material. The coating improves thermal conduction and heatremoval. In certain embodiments, the coating also enhances radio-opacityof the annuloplasty ring implant. Coating materials can be selected fromvarious groups of biocompatible organic or non-organic, metallic ornon-metallic materials such as Titanium Nitride (TiN), Iridium Oxide(Irox), Carbon, Platinum black, Titanium Carbide (TiC) and othermaterials used for pacemaker electrodes or implantable pacemaker leads.Other materials discussed herein or known in the art can also be used toabsorb energy.

In addition, or in other embodiments, fine conductive wires such asplatinum coated copper, titanium, tantalum, stainless steel, gold, orthe like, are wrapped around the selectively adjustable member to allowfocused and rapid heating of the selectively adjustable member whilereducing undesired heating of surrounding ring 1100 and/or tissues. Incertain such embodiments, the electrically conductive wires areelectrically insulated from other components of the ring 1100, such asthe shape memory material used in the plurality of segments 1102 and/orthe plurality of anchors 1104.

The energy source for activating the shape memory material of theselectively adjustable member may be surgically applied after the ring1100 has been implanted by percutaneously inserting a catheter into thepatient's body and applying the energy through the catheter. Forexample, RF energy, light energy, or thermal energy (e.g., from aheating element using resistance heating) can be transferred to theselectively adjustable member through a catheter positioned on or nearthe selectively adjustable member. Alternatively, thermal energy can beprovided to the shape memory material by injecting a heated fluidthrough a catheter or circulating the heated fluid in a balloon throughthe catheter placed in close proximity to the selectively adjustablemember. As another example, the shape memory material in the selectivelyadjustable member can be coated with a photodynamic absorbing materialthat is activated to heat the selectively adjustable member whenilluminated by light from a laser diode or directed to the coatingthrough fiber optic elements in a catheter. In certain such embodiments,the photodynamic absorbing material includes one or more drugs that arereleased when illuminated by the laser light. In certain embodiments, asubcutaneous electrode or coil couples energy from a dedicatedactivation unit. In certain such embodiments, the subcutaneous electrodeprovides telemetry and power transmission between the system and theannuloplasty ring. The subcutaneous electrode allows more efficientcoupling of energy to the implant with minimum or reduced power loss. Incertain embodiments, the subcutaneous energy is delivered to theselectively adjustable member via inductive coupling.

In other embodiments, the energy source is applied in a non-invasivemanner from outside the patient's body. In certain such embodiments, theexternal energy source is focused to provide directional heating to theshape memory material of the selectively adjustable member so as toreduce or minimize damage to the surrounding tissue. For example, incertain embodiments, a handheld or portable device including anelectrically conductive coil generates an electromagnetic field thatnon-invasively penetrates the patient's body and induces a current inthe selectively adjustable member. The current heats the selectivelyadjustable member and causes the shape memory material therein totransform to a memorized shape. In certain such embodiments, theselectively adjustable member also includes an electrically conductivecoil wrapped around or embedded in the memory shape material. Theexternally generated electromagnetic field induces a current in theselectively adjustable member's coil, causing it to heat and transferthermal energy to the shape memory material therein.

By way of example, FIGS. 15A, 15B, and 15C are schematic diagrams ofcircuitry for using RF induction to activate the shape memory materialof the internal glide ribbon 1210 according to one embodiment. FIG. 15Aillustrates circuitry located in a selectively adjustable annuloplastyring and FIG. 15B illustrates circuitry of an external (i.e., externalto the patient) RF induction activation system according to oneembodiment. FIG. 15C is a block diagram of a system 1520 for inductivelyactivating a selectively adjustable member 1522 (e.g., the internalglide ribbon 1210) of a ring according to certain embodiments.

Referring to FIGS. 15A, 15B, and 15C, the RF induction activation system1520 includes a power source 1524 (also referred to herein as an RFgenerator or RFG) capable of creating an alternating electrical signalof suitable power. The power source 1524 is connected to a delivery coil1526 tuned to resonate at the same frequency as the output of the powersource 1524. A capacitor 1528 is used to tune the delivery coil 1526 toresonate at the desired frequency. The implantable dynamicallyadjustable annuloplasty ring assembly includes a second (receiving) coil1530 positioned within the patient that is designed to resonate atsubstantially the same frequency as that of the delivery coil 1526connected to the power source 1524. A capacitor 1532 is used to tune thereceiving coil 1530 to resonate at the desired frequency. The receivingcoil 1530 is connected to a heating element 1534 (represented by aresistance R1 in FIG. 15A) wrapped around the selectively adjustablemember 1522 (as shown in FIG. 15C). To activate the annuloplasty ring,the delivery coil 1526 is placed near the receiving coil 1530 of theselectively adjustable member 1522 (e.g., near the patient's chest) andswitched on. Power from the resonating magnetic field 1536 (shown inFIG. 15C) is then inductively transferred across the skin barrier to thereceiving coil 1530 and converted to electrical current that issubsequently used to heat the selectively adjustable member 1522. In anexample embodiment, the inductance frequency is above about 1100 kHz sothat any leakage current that may come in contact with the patient wouldnot cause uncomfortable sensations during activation.

In certain embodiments, embedded computing and/or remote temperaturesensing is used. For example, FIG. 15C shows that additional circuitry1538 may be implanted in the patient. The additional circuitry 1538 mayinclude transmitter circuitry (including an antenna 1540), amicroprocessor, power circuitry, and temperature measuring circuitry(e.g., one or more thermocouple (TC) devices 1542, coupled to theadditional circuitry 1538). Similarly, the RFG 1524 may include receivercircuitry 1544 (including an antenna 1546) for receiving temperature andother data from the additional circuitry 1538 implanted in the patient.Although not shown, the RFG 1524 may also include a processor forprocessing and displaying the information received from the additionalcircuitry 1538 implanted within the patient.

The information received from the additional circuitry 1538 may include,for example, the power induced in the selectively adjustable member1522. In one embodiment, the power transferred to the selectivelyadjustable member 1522 is measured by reading the voltage across theselectively adjustable member 1522 and/or heating element 1534 and,because the resistance of the selectively adjustable member 1522 and/orheating element 1534 is known, the power can be calculated andcommunicated to the RFG 1524 by the telemetry link. In another example,the temperature and size of the selectively adjustable member 1522 maybe sensed and sent by transmitter circuitry in the additional circuitry1538 to the receiving circuitry 1544 via radiotelemetry. Temperature maybe sensed using the thermocouple device 1542, and the size of the ringmay be deduced via built in strain gauges 1548 (e.g., differentresistance values equal a proportional change in size).

In one embodiment, the RFG 1524 automatically finds a resonant point.The RFG 1524 may be programmed to analyze wattage delivered duringoperation (e.g., as discussed above) and may adjust the output frequencyto increase or maximize the greatest power transfer. This may beaccomplished in certain embodiments by directly monitoring the currentoutput on the delivery coil 1526, or the peak voltage induced in thereceiving coil 1530 via telemetry.

In one embodiment, the system 1520 is capable of multiple resonantfrequencies. For example, the heating element 1534 (coupled to theselectively adjustable member 1522) may be electrically connected tomore than one coil—each coil having a different natural resonance. Inanother embodiment, different coils may be attached to different heatingelements or devices in the ring that can be operated separately. Thetransmitting power source 1524 may have a set of coils (e.g., includingthe delivery coil 1526) that can be selectively used to couple to itsrespective sister coil (e.g., including the receiving coil 1530) coupledto the selectively adjustable member 1522.

By using this wireless technique of power transmission, the patient maybe electrically isolated from the system 1520 during activation of animplanted device. Thus, the possibility of electrocution due to a groundfault is eliminated and/or reduced.

In some embodiments, centering of coils is used. Such embodiments usetechniques of aligning the coils, such as through the use of physicallandmarks molded into a housing of the implanted receiving coil,magnets, and/or infrared lighting. For example, an infrared lightemitting diode (LED) may be installed on the implanted receiving coil1530 and may light during activation. An infrared detector located onthe delivery coil 1526 may be configured to give a user feedback on howmuch light it receives. A set of magnets may also be strategicallyplaced in the delivery coil 1526 and receiving coil 1530. As the magnetsare brought close together, the magnetic attraction may be utilized toalign the coils 1526, 1530.

Example Ring Embodiments With Linear Anchors

FIG. 16A is a schematic diagram illustrating a perspective view of asegmented annuloplasty ring 1600 including a plurality of linear anchors1610 according to one embodiment. Seven linear anchors 1610 are shown.However, artisans will understand from the disclosure herein that morelinear anchors 1610 or fewer linear anchors may be used. For example,certain embodiments may use ten or more linear anchors 1610.

The segmented annuloplasty ring 1600 includes a plurality of segments1612 at least partially cut into a shape memory hypotube that forms a“D-shape” in the annular operable geometry (e.g., when implanted aroundthe annulus) and may be compressed into a compressed delivery geometryfor implanting the ring 1600 within a patient's heart through acatheter. As discussed above with respect to FIG. 11, the ring 1600 mayalso include a ring closure lock 1614 (shown in a connected or lockedposition) for snap locking the two ends of the ring together.

As discussed above with respect to other embodiments, the ring 1600includes a plurality of anchor deployment windows 1618 cut into theshape memory hypotube. The plurality of linear anchors 1610 may beselectively deployed through the windows 1618 in a manner similar tothat described above for curved anchors 1104.

FIG. 16B is a schematic diagram illustrating a side view of a portion ofthe annuloplasty ring shown in FIG. 16A. As shown in FIG. 16B, incertain embodiments, the deployed linear anchors 1610 form an angle β(e.g., about 145 degrees) with a plane 1620 of the ring 1600 to providethe linear anchors 1610 with improved access to the valve annulus whenthe ring is positioned against the valve annulus. During anchordeployment, the plane 1620 of the ring 1600 is substantially parallel tothe plane of the valve annulus. As shown in FIG. 16B, the linear anchors1610 may include a pointed prong 1621 for penetrating tissue and a barb1622 that secures the anchor to the tissue.

FIG. 17 is a simplified schematic diagram illustrating a side view of aninternal anchor member 1700 including linear anchors 1710 according toone embodiment. The linear anchors 1710 may be affixed (e.g., laserwelded) to the internal anchor member 1700. In the embodiment shown inFIG. 17, however, the internal anchor member 1700 and linear anchors1710 are cut from a single superelastic shape memory (e.g., Nitinol)hypotube. FIG. 17, for example, shows remaining tubular portions 1712after the hypotube is cut to form prongs 1714 of the linear anchors1710. The remaining tubular portions 1712 facilitate sliding (e.g.,using wires or sutures accessible through the catheter) the internalanchor member 1700 coaxially within the hollow tube of the ring (e.g.,within the segmented annuloplasty ring 1600 shown in FIG. 16).

The internal anchor member 1700 is heat set to the same memorizedannular shape as the ring. The anchors prongs 1714 can be heat set toprotrude outward through windows cut in the segmented annuloplasty ring1600. Barbs 1716 may be laser welded to the prongs 1714 to form thelinear anchors 1710. The linear anchors 1710 are retracted/deployed bysliding the internal anchor member 1700 within the segmentedannuloplasty ring 1600.

FIG. 18A is a schematic diagram illustrating an enlarged perspectiveview of a single-barbed anchor 1808 of a percutaneous transcatheterannuloplasty ring 1800 in an affixation configuration according to oneembodiment. The anchor 1808 includes a prong 1810 and a single barb 1812welded to the prong 1810. The prong 1810 is integrated with or connectedto an inner tube member (not shown, but see FIG. 17) and protrudesthrough a window 1820 cut in an outer tube member formed by a pluralityof segments 1802.

FIG. 18B is a schematic diagram of an enlarged perspective view of adual-barbed anchor 1858 of a percutaneous transcatheter annuloplastyring in an affixation configuration according to one embodiment. Theanchor 1858 includes a prong 1860 and two barbs 1862 welded to the prong1860. The prong 1860 is integrated with or connected to an inner tubemember (not shown) and protrudes through a window 1820 cut in an outertube member formed by a plurality of segments 1852.

FIG. 19 is a simplified schematic diagram illustrating a side view ofthe internal anchor member 1700 shown in FIG. 17 and a selectivelyadjustable member 1900 according to one embodiment. As discussed above,the selectively adjustable member 1900 is configured to change the sizeand/or shape of the annuloplasty ring 1600 postoperatively to compensatefor changes in the size of the heart and/or the treated heart valve. InFIG. 19, the selectively adjustable member 1900 is shown passing throughthe remaining tubular portions 1712 of the cut hypotube of the internalanchor member 1700. In such embodiments, the selectively adjustablemember 1900 may be rod shaped and may have an outer diameter of about140 microns. In other embodiments, the selectively adjustable member1900 may be located adjacent to the internal anchor member 1700 (e.g.,around the external circumference, the internal circumference, orlateral to the internal anchor member 1700).

The selectively adjustable member 1900 includes a shape memory material(e.g., NiTi Alloy-B) that is responsive to changes in temperature and/orexposure to a magnetic field. The selectively adjustable member 1900 maybe activated, for example, using any of the energy sources or methodsdescribed above with respect to FIGS. 15, 15A, 15B, and 15C. Theactivated geometry of the selectively adjustable member 1900, accordingto certain embodiments, reduces the size of the mitral valve annulus inthe AP direction.

FIG. 20 is a schematic diagram illustrating a partial cross-sectionalview of the selectively adjustable member 1900 shown in FIG. 19according to one embodiment. The selectively adjustable member 1900 inthis example includes a shape memory rod 2010, a heating element 2012(e.g., electrically conductive wire) coiled around the shape memory rod2010, and an electrically insulating cover 2013 surrounding the shapememory rod 2010 and heating element 2012. The electrically insulatingcover 2013 prevents current passing through the heating element 2012from flowing to nearby metals or other shape memory alloys in the ring(e.g., the outer segmented annuloplasty ring 1600 and/or the internalanchor member 1700), or to surrounding tissue. The electricallyinsulating cover 2013 may also provide thermal insulation to protect thesurrounding tissue from excessive heat.

As shown in FIG. 20, the selectively adjustable member 1900 may includeleads 2014, 2016 for providing induced current through the heatingelement 2012. The leads 2014, 2016 may exit through the septal wall, theright atrium subclavian vein, or both leads may follow the ring contourand exit at P₁/P₂ leaflet junction or P₃/P₂ leaflet junction.

In certain embodiments, the receiving coil 1530 (shown in FIGS. 15A and15C) and any associated internal circuitry may be placed anywhere withinthe patient and outside the heart of the patient. For example, thereceiving coil 1530 and/or additional circuitry 1538 may be implantedimmediately below the surface of the skin and coupled to the heatingelement 2012 (coupled to the selectively adjustable member 1900) via oneor more wires extending into the heart. In another embodiment, thereceiving coil 1530 and associated internal circuitry may be integratedwith the annuloplasty ring and/or the selectively adjustable member1900. For example, the receiving coil 1530 and additional circuitry 1538may be incorporated internal to the annuloplasty ring. In still anotherembodiment, the receiving coil 1530 may be implanted adjacent the leadwire and/or the receiving coil, in close proximity to the selectivelyadjustable member 1900.

FIG. 21A is a schematic diagram illustrating a percutaneoustranscatheter annuloplasty ring 2100 according to another embodiment.The annuloplasty ring 2100 is shown in FIG. 21A in an annular operablegeometry with anchors 2108 in an introduction configuration. FIG. 21B isa schematic diagram illustrating an enlarged side view of theannuloplasty 2100 ring of FIG. 21A. The annuloplasty ring 2100 mayinclude an inner support structure 2140 and an outer shell 2142. In FIG.21A, the inner support structure 2140 is shown in phantom lines as beinghidden by the outer shell 2142. The inner support structure 2140 may beformed of a plurality of segments 2102, as shown in FIG. 1D anddiscussed more fully in other embodiments disclosed herein. The outershell 2142 may be formed of a thin super-elastic material, such asNitinol. The anchors 2108 may extend from and/or be integrated with theouter shell 2142. Superelastic shape memory material in the plurality ofsegments 2102 of the inner support structure 2140 and/or the outer shell2142 enable the annuloplasty ring 2100 to transition between aninsertion geometry and an operable geometry.

The anchors 2108, when in an introduction configuration, may be foldedor wrapped to lie in close proximity to the outer shell 2142, as shownin FIG. 21B, so as to not protrude away from the surface of theannuloplasty ring 2100. The anchors 2108 may include a prong 2152 and abarb 2154 at an end of the prong. The barb 2154 may facilitatesecurement of the anchor 2108 in tissue.

FIG. 21C is a schematic diagram of the annuloplasty ring 2100 of FIG.21A with the anchors 2108 in an affixation configuration protruding awayfrom the annuloplasty ring 2100. An integrated diaphragm 2162 may beintegrated with the outer shell 2142 and/or the inner support structure2140. Inflation of the integrated diaphragm 2162 unfurls the anchors2108 to expose the barbs 2154 for affixation (implantation) of theannuloplasty ring 2100 into a heart valve annulus. In anotherembodiment, rather than including an integrated diaphragm 2162, aballoon catheter (not shown) may be used to deploy the anchors 2108.

Those having skill in the art will understand from the disclosure hereinthat many changes may be made to the details of the above-describedembodiments without departing from the underlying principles of theinvention. The scope of the present invention should, therefore, bedetermined only by the following claims.

What is claimed is:
 1. A system for percutaneous transcatheter deliveryof an annuloplasty ring to repair a target valve of a heart via atrans-apical approach, the delivery apparatus comprising: a guide sheathhaving a lumen therethrough and configured to be positioned into theheart via an access site through a wall of the heart at the apex of theheart, the guide sheath having a length configured to be positionedthrough a ventricle of the heart, retrograde through the target valve,and into an atrium of the heart; a delivery assembly configured to bepositioned within the guide sheath and advanced to a distal portion ofthe guide sheath; and the annuloplasty ring configured to be arranged ina compressed delivery geometry within a plane that is transverse to alongitudinal axis of the lumen of the guiding sheath, wherein theannuloplasty ring comprises a plurality of anchors configured to bepressed into and engage tissue of an annulus of the target valve.
 2. Thesystem of claim 1, wherein the delivery assembly comprises a balloonassembly comprising: an upper balloon portion defining an upper surfaceof a recess and configured to inflate to restrict distal shifting of theannuloplasty ring relative to the recess as the delivery assembly isadvanced and positioned in the target valve; and a lower balloonportion, defining a lower surface of the recess and configured toinflate to restrict proximal shifting of the annuloplasty ring relativeto the recess as the delivery assembly is advanced and positioned in thetarget valve; wherein the upper balloon portion and the lower balloon ofthe balloon assembly are more pliant than the recess of the balloonassembly to inflate and expand more readily than the recess, and whereininflation of the balloon assembly to cause expansion of the recessexpands the annuloplasty ring from the compressed delivery geometry toan expanded operable geometry.
 3. The system of claim 1, wherein thedelivery assembly comprises a balloon assembly comprising: an upperballoon defining an upper surface of a recess and configured to inflateto a diameter larger than the annulus of the target valve to restrictdistal shifting of the annuloplasty ring and provide a surface that canbe withdrawn to secure the annuloplasty ring against the annulus of thetarget valve; and a lower balloon defining a lower surface of the recessand configured to inflate to expand the annuloplasty ring from thecompressed delivery geometry to an expanded operable geometry, whereinthe annuloplasty ring in the compressed delivery geometry is disposedwithin the recess of the balloon assembly.
 4. The system of claim 3,wherein the balloon assembly comprises a double lumen shaft coupling theupper balloon and the lower balloon, the double lumen shaft having afirst lumen coupled to and configured to direct a fluid or gas into theupper balloon from outside the heart and having a second lumen coupledto and configured to direct a fluid or gas into the lower balloon fromoutside the heart.
 5. The system of claim 1, wherein the annuloplastyring comprises free ends configured to be snapped together to decrease adiameter of the annuloplasty ring and thereby decrease a diameter of theannulus of the target valve.
 6. The system of claim 1, wherein theannuloplasty ring comprises shape memory material and a heating elementto heat the shape memory material, the shape memory material configuredto decreasing the diameter of the annuloplasty ring in response to heatprovided by the heating element.
 7. The system of claim 1, furthercomprising a cinching mechanism configured to cinch the annuloplastyring to reduce a diameter of the annuloplasty ring.
 8. The system ofclaim 1, wherein the anchors of the annuloplasty ring are configured tobe deployed by pulling one or more sutures coupled to the anchors, thesutures extending through the guide sheath and out of the access site ofthe heart.
 9. The system of claim 1, further comprising a knot pusherconfigured to knot the suture and push the suture from outside the heartto a point inside the heart adjacent the annuloplasty ring.